[Federal Register Volume 67, Number 119 (Thursday, June 20, 2002)]
[Rules and Regulations]
[Pages 41823-41825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15633]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 529


Certain Other Dosage Form New Animal Drugs; Progesterone 
Intravaginal Inserts

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by DEC International, Inc. The NADA provides for use of 
progesterone intravaginal inserts for manipulation of estrus in cattle.

DATES: This rule is effective June 20, 2002.

FOR FURTHER INFORMATION CONTACT: Harlan J. Howard, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0231, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: DEC International, Inc., 1919 South 
Stoughton Rd., P.O. Box 8050, Madison WI 53708-8050, filed NADA 141-200 
that provides for use of EAZI-BREED CIDR Progesterone Intravaginal 
Inserts for synchronization of estrus in suckled beef cows and 
replacement beef and dairy heifers, for advancement of first postpartum 
estrus in suckled beef cows, and for advancement of first pubertal 
estrus in replacement beef heifers. The NADA is approved as of May 2, 
2002, and the regulations in 21 CFR part 529 are amended by adding 
Sec. 529.1940 to reflect the approval. The regulation in 21 CFR 522.690 
is being amended to add a cross-reference for the concurrent use of 
dinoprost solution by intramuscular injection and is being revised to 
reflect a current format. The basis of approval is discussed in the 
freedom of information summary.
    In addition, DEC International, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for the firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning May 2, 2002.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 522 and 529

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
522, and 529 are amended as follows:

[[Page 41824]]

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``DEC International, Inc.'' and in 
the table in paragraph (c)(2) by numerically adding an entry for 
``067080'' to read as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
*                    *                    *                    *
                    *                    *                    *
DEC International, Inc., 1919 South Stoughton  067080
 Rd., P.O. Box 8050, Madison, WI 53708-8050
*                    *                    *                    *
                    *                    *                    *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
*                    *                    *                    *
                    *                    *                    *
067080                       DEC International, Inc., 1919 South
                              Stoughton Rd., P.O. Box 8050, Madison, WI
                              53708-8050
*                    *                    *                    *
                    *                    *                    *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    4. Section 522.690 is revised to read as follows:


Sec. 522.690  Dinoprost solution.

    (a) Specifications. Each milliliter (mL) of solution contains 
dinoprost tromethamine equivalent to 5 milligrams (mg) dinoprost.
    (b) Sponsors. See Nos. 000009 and 059130 in Sec. 510.600(c) of this 
chapter.
    (c) Special considerations. (1) Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) Women of child-bearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme 
caution when handling this product. Dinoprost tromethamine is readily 
absorbed through the skin and can cause abortion and bronchiospasms. 
Accidental spillage on the skin should be washed off immediately with 
soap and water.
    (d) Conditions of use--(1) Horses--(i) Amount. 1 mg per 100 pounds 
of body weight as a single intramuscular injection.
    (ii) Indications. For its luteolytic effect to control timing of 
estrus in estrus cycling mares and in clinically anestrous mares that 
have a corpus luteum.
    (iii) Limitations. Not for use in horses intended for food.
    (2) Cattle--(i) Beef cattle and nonlactating dairy heifers--(A) 
Amount. 25 mg as an intramuscular injection either once or twice at a 
10- to 12-day interval.
    (B) Indications. For its luteolytic effect to control timing of 
estrus and ovulation in estrous cycling cattle that have a corpus 
luteum.
    (ii) Beef cattle and nonlactating dairy heifers--(A) Amount. 25 mg 
as a single intramuscular injection.
    (B) Indications. For treatment of pyometra (chronic endometritis).
    (iii) Nonlactating cattle--(A) Amount. 25 mg as a single 
intramuscular injection during the first 100 days of gestation.
    (B) Indications. For its abortifacient effect in nonlactating 
cattle.
    (iv) Lactating dairy cattle--(A) Amount. 25 mg as a single 
intramuscular injection.
    (B) Indications. For treatment of unobserved (silent) estrus in 
lactating dairy cattle that have a corpus luteum.
    (v) Dinoprost solution as provided by No. 000009 in Sec. 510.600(c) 
of this chapter may be used concurrently with progesterone intravaginal 
inserts as in Sec. 529.1940 of this chapter.
    (3) Swine--(i) Amount. 10 mg as a single intramuscular injection.
    (ii) Indications. For parturition induction in swine when injected 
within 3 days of normal predicted farrowing.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    5. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    6. Section 529.1940 is added to read as follows:


Sec. 529.1940  Progesterone intravaginal inserts.

    (a) Specifications. Each insert contains 1.38 grams of progesterone 
in molded silicone over a nylon spine.
    (b) Sponsor. See No. 067080 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.540(a) of this chapter.
    (d) Special considerations. (1) Wear latex gloves when handling 
inserts. Store removed inserts in a plastic bag or other sealable 
container until they can be disposed in accordance with applicable 
local, State, and Federal regulations.
    (2) This product is approved with the concurrent use of dinoprost 
solution on day 6 of the 7-day administration period. See 
Sec. 522.690(c) of this chapter.
    (e) Conditions of use--(1) Amount. Administer one intravaginal 
insert per animal for 7 days. Administer 25 milligrams (mg) dinoprost 
(5 milliliters (mL) of 5 mg/mL solution as in Sec. 522.690(a) of this 
chapter) 1 day prior to insert removal.
    (2) Indications for use. For synchronization of estrus in suckled 
beef cows and replacement beef and dairy heifers, for advancement of 
first postpartum estrus in suckled beef cows, and for advancement of 
first pubertal estrus in replacement beef heifers.
    (3) Limitations. Do not use in animals with abnormal, immature, or 
infected genital tracts; or in beef cows that are fewer than 20 days 
postpartum; or in beef or dairy heifers of insufficient size or age for 
breeding; or in lactating dairy cows. Do not use an insert more than 
once. To prevent the potential transmission of venereal and bloodborne 
diseases, the inserts should

[[Page 41825]]

be disposed after a single use. Administration of vaginal inserts for 
periods greater than 7 days may result in reduced fertility. Dinoprost 
solution as provided by No. 000009 in Sec. 510.600(c) of this chapter.

    Dated: June 6, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-15633 Filed 6-19-02; 8:45 am]
BILLING CODE 4160-01-S